Effect of Micronutrients and Life Skills Education on the Health and Nutrition of Adolescent and Young Women in Pakistan

Last updated: July 26, 2021
Sponsor: Aga Khan University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Anemia

Pregnancy

Treatment

N/A

Clinical Study ID

NCT03287882
4324-Ped-ERC-16
  • Ages 15-24
  • Female
  • Accepts Healthy Volunteers

Study Summary

The primary aims of this study are: 1) To evaluate the impact of supplementation with multiple micronutrients (MMN) from preconception and life skills education among women 15-18.9 years of age at enrolment on the prevalence of anemia in a population setting; and 2) To evaluate the impact of supplementation with MMN from preconception and life skills education among young women 15-24 years of age on the rate of low birth weight (LBW) in a population setting. Infants born to mothers enrolled in the study will be followed for 1 year. This study aims to enrol 25,400 non-pregnant young women in Matiari district. This sample size is anticipated to equate to 1456 births. Participants will be randomized by cluster to receive either MMN supplements and life skills education or the standard of care at enrolment. Clusters have been defined based on health facility catchment areas. MMN supplements will be provided twice weekly during the preconception period, once daily during the pregnancy period, and once daily until 6 months after giving birth during the postpartum period; and a package of life skills education materials will be provided bi-monthly during the preconception period. In addition to the primary outcomes, measurements will include micronutrient status, anthropometrics, birth outcomes, dietary intake and feeding practices, adherence, and indices of empowerment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Minimum age at enrolment: 15 years
  • Maximum age at enrolment: 23 years
  • Any marital status
  • Intend to comply with study intervention and follow up

Exclusion

Exclusion Criteria:

  • Women participating in other nutrition trials
  • Women who intend to leave the study area
  • Women who are already pregnant

Study Design

Total Participants: 25447
Study Start date:
June 30, 2017
Estimated Completion Date:
February 28, 2022

Connect with a study center

  • Matiari Research and Training Centre

    Matiari, Sindh
    Pakistan

    Site Not Available

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